- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01764074
Brief Sleep Intervention for Bipolar Disorder
Brief Sleep Intervention for Suicide in Bipolar Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bipolar disorder is characterized by episodes of depression as well as episodes of mania (abnormally high mood). Individuals with bipolar disorder experience high rates of suicidal ideation and behavior, with risk of death due to suicide estimated to be 20 times greater than the general population. Moreover, some research suggests that among individuals treated for bipolar disorder, approximately 40% will report a past suicide attempt. Other studies suggest that between 25 and 65% of patients with bipolar disorder will attempt suicide and that between 4 and 19% of these individuals will be successful. Among the DSM-IV-TR Axis I disorders, suicide appears to be the highest in bipolar disorder. Individuals with bipolar disorder have a greater likelihood of both current and past suicidal ideation if they have an anxiety disorder, have an earlier age of onset, or a more severe course of illness. Nevertheless, there is a continued need for information on the epidemiology and risk factors for suicidal ideation and behavior in this population.
Several studies have shown that sleep difficulties (i.e., insomnia, hypersomnia, poor sleep quality, and nightmares) are significantly associated with suicidal ideation, even after controlling for depression. These disturbances are well documented during episodes of depression and mania, but sleep disturbances have also been shown to persist during periods of relative mood stability. A common symptom in bipolar patients experiencing manic episodes is a reduced need for sleep, and several studies using polysomnography have identified decreased REM sleep latency in manic episodes. Utilizing self-report measures, studies of bipolar patients in depressive episodes have identified variable rates of hypersomnia and insomnia as common factors. However, research conducted using laboratory-based polysomnography during depressive episodes have reported disparate findings.
This proposal involves a test of a novel measure of sleep architecture in patients with bipolar disorder, using a newly available home sleep monitoring device called Embla (www.embla.com). This device sticks to the skin on the chest with standard EKG-adhesive stickers and captures electrocardiogram (EKG) during sleep. The Embla device also measures movement, snoring, body position, and light levels. The on-board storage allows 2-3 weeks of nightly recording. By using an unobtrusive and potentially informative measure of sleep architecture, this protocol will allow longitudinal, objective information about sleep disturbance to be compared with corresponding mood states in patients with bipolar disorder.
Overall, this protocol is investigating the relationship between suicidality and sleep disturbance as well as assessing whether a brief CBT intervention for sleep disturbance is associated with reduced suicidal ideation and/or behavior. Since research suggests that CBT is an effective adjunct treatment for reducing suicidality in this population, and that treatment for insomnia can improve sleep in individuals with bipolar disorder, the present research has important implications for the prevention and intervention of suicide in this vulnerable population. To the investigators knowledge, no investigations have looked at the effectiveness of CBT on both sleep and suicidality in bipolar disorder. Furthermore, while past research has relied almost exclusively on subjective reports of sleep, this study captures both subjective and objective measures of sleep.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-65.
- Have a primary diagnosis of bipolar I or bipolar II disorder
- Have a reported sleep disturbance
- Have reported suicide ideation (thoughts)
Exclusion Criteria:
- Any known or active sleep disorder (such as sleep apnea)
- Any history of significant cardiac, pulmonary, neurological, hepatic, or renal disease
- Any history of malignancy, chemotherapy, or radiation
- Any skin condition that would prevent wearing the device
- Pregnancy
- Current or suspected sleep apnea
- Current use of certain medications including beta blockers
- Known diagnosis of atrial fibrillation
- Acute major depressive or manic episode
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief Sleep Intervention
Every participant in the study will complete a 3-session sleep intervention with a clinician to improve sleep problems such as insomnia or hypersomnia.
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Participants will meet with a therapist for three sessions to try to improve sleep problems (hypersomnia or insomnia, depending on the problems the participant has).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High Frequency Coupling (HFC)
Time Frame: 6 weeks
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High Frequency Coupling (HFC) is a measure of the portion of unstable versus stable sleep, and this is measured by the Embla device. HFC has been validated in a variety of circumstances, and correlates with cardiovascular and mental health outcomes(Thomas, 2006). |
6 weeks
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Modified Scale of Suicidal Ideation (MSSI)
Time Frame: 5 weeks
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The MSSI is a 19-item clinical research instrument designed to quantify and assess suicidal intention.
|
5 weeks
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The Columbia-Suicide Severity Rating Scale (CSSRS)
Time Frame: 5 weeks
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The CSSRS records suicidal behavior on the basis of attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, and preparatory acts or behaviors.
|
5 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 5 weeks
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The MADRS is a 10-item clinician-rated scale to measure the overall severity of depressive symptoms.
|
5 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of rapid eye movement (REM) sleep
Time Frame: 5 weeks
|
5 weeks
|
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 5 weeks
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9-item self-rated questionnaire that measures sleep quality and sleep disturbance over the past month
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5 weeks
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Young Mania Rating Scale (YMRS)
Time Frame: 5 weeks
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The YMRS aims to quantify the degree of mania in patients who already have a diagnosis of BD and is the most widely studied instrument for mania
|
5 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Louisa G Sylvia, Ph.D., Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRG-0-071-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bipolar Disorder
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ProgenaBiomeRecruitingBipolar Disorder | Bipolar I Disorder | Bipolar II Disorder | Bipolar Type I Disorder | Bipolar Disorder Mild | Bipolar Disorder Moderate | Bipolar Disorder SevereUnited States
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University of PittsburghNational Alliance for Research on Schizophrenia and DepressionCompletedBipolar I Disorder | Bipolar II Disorder | Bipolar Disorder NOSUnited States
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Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationCompletedBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar Disorder I | Bipolar Affective DisorderUnited States
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Region StockholmKarolinska InstitutetRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, ModerateSweden
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Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do Sul; Hospital Moinhos de VentoActive, not recruitingBipolar Disorder | Bipolar Depression | Major Depressive Disorder | Bipolar I Disorder | Affective Disorder | Bipolar II DisorderBrazil
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Medical University of South CarolinaMilken InstituteCompletedBipolar Disorder | Bipolar I Disorder | Bipolar II DisorderUnited States
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Joshua RosenblatRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
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Mayo ClinicCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
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Joshua RosenblatRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
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Myriad Genetic Laboratories, Inc.University of MinnesotaCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
Clinical Trials on Brief Sleep Intervention
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i4HealthTerminated
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Beth Israel Deaconess Medical CenterCompletedIrritable Bowel Syndrome | Sleep DisturbanceUnited States
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New York State Psychiatric InstituteNot yet recruitingDepression | Mental Health Disorder | Adolescent Behavior | Stigma, SocialUnited States
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University of Texas at AustinNational Institute on Drug Abuse (NIDA)Completed
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Solveig MagnusdottirMyCardioLLCCompleted
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Friends Research Institute, Inc.National Institute on Drug Abuse (NIDA)CompletedDrug Abuse | HIV Risk BehaviorUnited States
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Wayne State UniversityNational Institute on Drug Abuse (NIDA)Completed
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Ohio State UniversityCompletedDepression | Heart Failure | Sleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Anxiety | Congestive Heart Failure | Cardiac Failure | Disorders of Initiating and Maintaining SleepUnited States